Label: INSTANT HAND SANITIZER- hand sanitizer liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 6mg/mL. Purpose: Antimicrobial

  • Purpose

    Antimicrobial.

  • Use

    Antibacterial, hands sterilizer, is specially formulated to clean and sanitising hands.

  • Warnings

    For the external use only.

  • DO NOT USE

    Do not use near the eyes.

    In case of contact with the eyes, wash with plenty of water immediately and seek medical advice.

  • WHEN USING

    When using: avoid direct contact with eyes and damaged skin; if it gets in your eyes accidentally, please rinse with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply the product to the hands and do over palms, fingers, and back of hands.

  • Other information

    Storage in cool conditions.

  • Inactive ingredients

    Deionized water (Aqua), AES, Propylene glycol, Vitamin E.

  • Package Label - Principal Display Panel

    500

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78421-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78421-1001-6500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Shijiazhuang Wanshun Dayly Chemical Factory (530897727)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shijiazhuang Wanshun Dayly Chemical Factory530897727manufacture(78421-1001) , label(78421-1001)
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